MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for NEUROPACE RNS SYSTEM RNS-320-K 1007694 manufactured by Neuropace, Inc..
[187170416]
(b)(4). The rns system remains implanted and programmed for detection. The treating center forwarded a cd containing a ct of the patient's implant to neuropace for analysis. Review of ct scan by the cmo of neuropace did not disclose anything unusual regarding rns system placement.
Patient Sequence No: 1, Text Type: N, H10
[187170417]
At a follow-up appointment on (b)(6) 2019, the patient reported experiencing a tingling sensation in her face which started after implant, however the patient had not previously reported the issue. The patient reported feeling the face sensation (tingling) even while stimulation was disabled. The patient returned to the treating center on (b)(6) 2020 where additional testing was performed and it was determined the patient also felt the sensation when she interrogated with her remote monitor or when interrogation was performed in the clinic with the tablet programmer. Stimulation remained disabled. Potential root cause may be related to lead placement near the dura. The patient was recently seen on (b)(6) 2020 where stimulation remains disabled but the treating center has identified a plan of action including an adjustment of her aeds and a slow reintroduction of stimulation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004426659-2020-00009 |
| MDR Report Key | 9868147 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RAMONA GONIS |
| Manufacturer Street | 455 N. BERNARDO AVE. |
| Manufacturer City | MOUNTAIN VIEW, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2382788 |
| Manufacturer G1 | NEUROPACE, INC. |
| Manufacturer Street | 455 N. BERNARDO AVE. |
| Manufacturer City | MOUNTAIN VIEW, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROPACE RNS SYSTEM |
| Generic Name | NEUROPACE RNS SYSTEM |
| Product Code | PFN |
| Date Received | 2020-03-23 |
| Model Number | RNS-320-K |
| Catalog Number | 1007694 |
| Lot Number | 27670-1-1-1 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUROPACE, INC. |
| Manufacturer Address | 455 N. BERNARDO AVE. MOUNTAIN VIEW, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-23 |